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Study protocol: quantitative fibronectin to help decision-making in women with symptoms of preterm labour (QUIDS) part 2, UK Prospective Cohort Study
  1. Sarah Jane Stock1,2,
  2. Lisa M Wotherspoon1,
  3. Kathleen Anne Boyd3,
  4. Rachel K Morris4,
  5. Jon Dorling5,
  6. Lesley Jackson6,
  7. Manju Chandiramani7,
  8. Anna L David8,9,
  9. Asma Khalil10,
  10. Andrew Shennan11,
  11. Victoria Hodgetts Morton4,
  12. Tina Lavender12,
  13. Khalid Khan13,
  14. Susan Harper-Clarke14,
  15. Ben Mol15,
  16. Richard D Riley16,
  17. John Norrie17,
  18. Jane Norman1
  1. 1 Tommy’s Centre for Maternal and Fetal Health, University of Edinburgh MRC Centre for Reproductive Health, Queen’s Medical Research Institute, Edinburgh, UK
  2. 2 School of Women’s and Infants’ Health, University of Western Australia, Crawley, Western Australia, Australia
  3. 3 Health Economics and Health Technology Assessment, Institute of Health and Wellbeing, University of Glasgow, Glasgow, UK
  4. 4 School of Clinical and Experimental Medicine, University of Birmingham, Birmingham, UK
  5. 5 Neonatal Unit, Queen’s Medical Centre, Nottingham, UK
  6. 6 Neonatal Unit, Royal Hospital for Children Glasgow, Glasgow, UK
  7. 7 Department of Surgery & Cancer, Reproductive Biology, Imperial College Healthcare NHS Trust, Queen Charlotte’s and Chelsea Hospital, London, UK
  8. 8 Institute for Women’s Health, University College London Medical School, London, UK
  9. 9 86-96 Chenies Mews, University College London Medical School London, London, UK
  10. 10 St. George’s Medical School, University of London, London, UK
  11. 11 Maternal and Fetal Research Unit, King’s College London, London, UK
  12. 12 School of Nursing, Midwifery and Social Work, University of Manchester, Manchester, UK
  13. 13 Centre for Primary Care and Public Health, Queen Mary University of London, London, UK
  14. 14 Patient and Public Involvement Representative
  15. 15 Department of Obstetrics and Gynaecology, Monash University, Melbourne, Victoria, Australia
  16. 16 Research Institute for Primary Care and Health Sciences, Keele University, Keele, UK
  17. 17 Edinburgh Clinical Trials Unit, University of Edinburgh, Edinburgh, UK
  1. Correspondence to Dr Sarah Jane Stock; sarah.stock{at}ed.ac.uk

Abstract

Introduction The aim of the QUIDS study is to develop a decision support tool for the management of women with symptoms and signs of preterm labour, based on a validated prognostic model using quantitative fetal fibronectin (fFN) concentration, in combination with clinical risk factors.

Methods and analysis The study will evaluate the Rapid fFN 10Q System (Hologic, Marlborough, Massachusetts, USA) which quantifies fFN in a vaginal swab. In QUIDS part 2, we will perform a prospective cohort study in at least eight UK consultant-led maternity units, in women with symptoms of preterm labour at 22+0 to 34+6 weeks gestation to externally validate a prognostic model developed in QUIDS part 1. The effects of quantitative fFN on anxiety will be assessed, and acceptability of the test and prognostic model will be evaluated in a subgroup of women and clinicians (n=30). The sample size is 1600 women (with estimated 96–192 events of preterm delivery within 7 days of testing). Clinicians will be informed of the qualitative fFN result (positive/negative) but be blinded to quantitative fFN result. Research midwives will collect outcome data from the maternal and neonatal clinical records. The final validated prognostic model will be presented as a mobile or web-based application.

Ethics and dissemination The study is funded by the National Institute of Healthcare Research Health Technology Assessment (HTA 14/32/01). It has been approved by the West of Scotland Research Ethics Committee (16/WS/0068).

Version Protocol V.2, Date 1 November 2016.

Trial registration number ISRCTN41598423 and CPMS: 31277.

  • pregnancy
  • preterm birth
  • fetal fibronectin
  • cervix
  • diagnostic test

This is an Open Access article distributed in accordance with the terms of the Creative Commons Attribution (CC BY 4.0) license, which permits others to distribute, remix, adapt and build upon this work, for commercial use, provided the original work is properly cited. See: http://creativecommons.org/licenses/by/4.0/

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Footnotes

  • Contributors SJS, KAB, RKM, JD, LJ, MC, ALD, AK, AS, VH-M, TL, KK, SH-C, BM, RDR, JN and JEN developed the protocol. SJS, LMW, RDR, KAB, TL and JN drafted the protocol. RKM, JD, LJ, MC, ALD, AK, AS, VH-M, KK, SH-C, BM and JEN reviewed and commented on the protocol.

  • Funding This project was funded by the National Institute of Healthcare Research Health Technology and Assessment (Reference 14/32/01). The views expressed are those of the authors and not necessarily those of the NHS, the NIHR or the Department of Health.

  • Competing interests SJS and JEN work at the University of Edinburgh, who received £1000 sponsorship from Hologic to support a meeting (The Society of Reproductive Investigation and MRC Centre for Reproductive Health Scientific Symposium on Targeting Inflammation to Improve Reproductive Health across the Lifecourse – August 2017). AS has in the past (over last 5 years; not in the last 3 years) received funding for expenses related to advisory board and internal staff education from Hologic. MC received sponsorship from Hologic to organise an educational teaching focusing on prediction of Preterm Birth at the 2017 annual meeting of the British Maternal and Fetal Medicine Society. Hologic, the makers of fFN have provided analysers and technical support for their use to sites participating in the QUIDS prospective cohort study. They have no access to the data, or other involvement in the conduct, data analysis, interpretation of results or decision to publish the results of the study.

  • Patient consent Not required.

  • Ethics approval A favourable ethical opinion has been obtained from the appropriate REC (reference 16/WS/0068).

  • Provenance and peer review The study was extensively peer reviewed as part of the process of gaining grant funding from the NIHR HTA (14/32/01).

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